The undersigned submits on behalf of the Cancer Prevention Coalition, Inc. (CPC), Samuel S. Epstein, M.D., Chair, Quentin Young, M.D., and Peter Orris, M.D., and on behalf of the Center for Constitutional Rights, Michael Deutsch, Esq. This citizen petition is based on recent scientific information on risks of brain cancer in children resulting from the use of lindane shampoo, other evidence of carcinogenicity, and evidence of haematoxicity and neurotoxicity.

The undersigned submits this petition under 21 U.S.C. 321 (n), 361, 362, and 371 (a); and 21 CFR 740.1, 740.2 of 21 CFR 10.30 of the Federal Food, Drug, and Cosmetic Act to request the Commissioner of the Food and Drug Administration (FDA) to immediately ban the use of lindane as a treatment for lice and scabies.

A. AGENCY ACTION REQUESTED

This petition requests that FDA take the following action:

Immediately ban the use of lindane as a treatment for lice and scabies.

Pursuant to 21 CFR 10.30 (h) (2), a hearing at which time we can present our scientific evidence.

B. STATEMENT OF GROUNDS

Lice and scabies are endemic among the population. An estimated six million Americans, mainly children, are infested with lice each year. Most children are treated with pesticide-containing products marketed as shampoos. Lindane (gamma-hexachlorocyclohexane) is one of the most widely prescribed treatments for lice and scabies.

In a recent case-control study, Davis, et al. reported a statistically significant increase of brain cancer in children following treatment with lindane shampoo. 1

These findings are of particular significance in relation to the striking increase, 38%, in the incidence of brain and nervous system cancers in children from 1973-1991S.2

Further evidence on cacinogenicity is provided by two epidemiological studies by the National Cancer Institute.3,4 Statistically significant increases, up to six-fold , in the incidence of non-Hodgkin's lymphoma were reported in farmers exposed to lindane.

In addition to these epidemiological data, series of case reports on blood disorders, including aplastic anemia, with case fatality rates of some 50%, and leukemia have appeared in the literature over the last three decades.5, 6 Of related interest is recent evidence on the high toxicity of lindane to human red blood stem cells. 7

These epidemiological data are further supported by experimental evidence on the carcinogenicity of lindane. Lindane is classified as Group 2B by the International Agency for Research on Cancer 8, and as 2B/C by the Environmental Protection Agency. The EPA has restricted lindane's use as an agricultural pesticide.9 Agricultural and other uses of lindane and other isomers of hexachlorocyclohexane have been severly restricted or banned by other countries.10

The neurotoxic effects of lindane are well known. A 1976 FDA alert was issued to warn physicians of such risks.11 Numreous case reports have documented seizures and brain damage following lindane exposure.12 Recent studies have emphasized that recommended dosages of lindane may cause seizures:13

"Therefore, given the extremely narrow range of safety of this drug and the risk imposed by the kindling effects, which potentiates convulsive seizures, and that this potentiation may be carried on for a considerable period of time, there is no good reason to use lindane in children or adults when other perfectly effective, safer pediculides are available."

Lindane is readily absorbed through the skin.14 After topical application to the adult skin without washing for 24 hours, almost 10% can be recovered from urine.15 Absorption is further increased when lindane is administered in warm water or followed by oil-based hair care preparations.

The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.

Because lindane is safe and effective if used as directed, the agency denies your request (1) to ban the use of lindane as a treatment for lice and scabies, and (2) to conduct a hearing under 21 CFR 10.30(h)(2) so that you can present your scientific evidence.